Smart sensor ports and methods of using same

ABSTRACT

The present disclosure provides an orientation-nonspecific sensor port for use in analyte meters designed to detect and quantify analyte levels in a fluid sample along with methods of using the same. The present disclosure also provides compositions and methods for facilitating the correct insertion of a sensor into a corresponding analyte meter.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/312,497, filed on Jun. 23, 2014, which is a continuation of U.S.patent application Ser. No. 12/644,487, filed on Dec. 22, 2009, now U.S.Pat. No. 8,771,486, which is a continuation of U.S. patent applicationSer. No. 12/431,672, filed on Apr. 28, 2009, now U.S. Pat. No.8,758,583, the disclosures of which are herein incorporated byreference.

BACKGROUND

Analytical sensors and meters are often used in chemistry and medicineto determine the presence and/or concentration of a biological analyteof interest. For example, such analytical sensors and meters are used tomonitor glucose in diabetic patients and lactate during critical careevents.

Many currently available analyte meters are configured such that asensor is inserted into the analyte meter during the testing process.Such meters are orientation specific in that they require that thecorresponding sensor is inserted in a specific orientation which allowsfor detection of a signal from the sensor and measurement of analyteconcentration. This orientation requirement complicates the testingprocess and, in the context of diabetes care, makes it more difficultfor certified diabetes educators to teach the correct use of thedevices. This problem may be compounded when the patient is a youngchild or suffers from impaired vision.

It would therefore be desirable and useful to develop an orientationnon-specific analyte meter, capable of performing an accurate andsensitive analysis of the concentration of analytes in a liquid sample.

SUMMARY OF THE INVENTION

The present disclosure provides orientation-nonspecific sensor ports foruse in analyte meters designed to detect and quantify analyte levels ina fluid sample along with methods of using the same. The presentdisclosure also provides compositions and methods for facilitating thecorrect insertion of a sensor into a corresponding analyte meter. Theseand other objects, features and advantages of the present disclosurewill become more fully apparent from the following detailed descriptionof the embodiments, the appended claims and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Referring now to the drawings, wherein like reference numerals andletters indicate corresponding structure throughout the several views:

FIG. 1 shows a first embodiment of an analyte meter according thepresent disclosure;

FIG. 2 shows an exploded view of an analyte sensor which is configuredsuch that it can be inserted in two effective orientations into theanalyte meter shown in FIG. 1;

FIG. 3 shows a second embodiment of an analyte meter according to thepresent disclosure;

FIG. 4 shows an exploded view of an analyte sensor which is configuredsuch that it can be inserted in two effective orientations into theanalyte meter shown in FIG. 3 or FIG. 5;

FIG. 5 shows a third embodiment of an analyte meter according to thepresent disclosure;

FIG. 6 shows an exploded view (A) and a top view (B) of an analytesensor which is configured such that it can be inserted in two effectiveorientations into the analyte meter shown in FIG. 5;

FIG. 7 shows a fourth embodiment of an analyte meter according to thepresent disclosure;

FIG. 8 shows an exploded view (A) and a top view (B) of an analytesensor which is configured such that it can be inserted in two effectiveorientations into the analyte meter shown in FIG. 7;

FIG. 9 shows three (A-C) exemplary demarcation schemes according to thepresent disclosure;

FIG. 10 is a flow chart showing an analyte concentration determinationand medication dose calculation procedure in accordance with anembodiment of the present disclosure;

FIG. 11 is a flow chart illustrating the medication dose calculationprocedure of FIG. 10; and

FIG. 12 is a flow chart showing an analyte concentration determinationand medication dose calculation procedure in accordance with analternative embodiment of the present disclosure.

Before the present invention is further described, it is to beunderstood that this invention is not limited to particular embodimentsdescribed, as such may, of course, vary. It is also to be understoodthat the terminology used herein is for the purpose of describingparticular embodiments only, and is not intended to be limiting, sincethe scope of the present invention will be limited only by the appendedclaims.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimit of that range and any other stated or intervening value in thatstated range, is encompassed within the invention. The upper and lowerlimits of these smaller ranges may independently be included in thesmaller ranges, and are also encompassed within the invention, subjectto any specifically excluded limit in the stated range. Where the statedrange includes one or both of the limits, ranges excluding either orboth of those included limits are also included in the invention.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although any methods andmaterials similar or equivalent to those described herein can also beused in the practice or testing of the present invention, the preferredmethods and materials are now described. All publications mentionedherein are incorporated herein by reference to disclose and describe themethods and/or materials in connection with which the publications arecited.

As used herein and in the appended claims, the singular forms “a,”“and,” and “the” include plural referents unless the context clearlydictates otherwise. It is further noted that the claims may be draftedto exclude any optional element. As such, this statement is intended toserve as antecedent basis for use of such exclusive terminology as“solely,” “only” and the like in connection with the recitation of claimelements, or use of a “negative” limitation.

The publications discussed herein are provided solely for theirdisclosure prior to the filing date of the present application. Nothingherein is to be construed as an admission that the present invention isnot entitled to antedate such publication by virtue of prior invention.Further, the dates of publication provided may be different from theactual publication dates which may need to be independently confirmed.

DETAILED DESCRIPTION

Analyte Meters

The present disclosure provides analyte meters designed to receiveanalyte sensors. The analyte meters are configured to process a signalreceived from the analyte sensor and determine a concentration ofanalyte based on the received signal. In some embodiments, the analytemeters are specifically designed to receive an analyte sensor in anorientation non-specific manner making it easier for a user to operatethe analyte meter and the corresponding sensor.

The analyte meters may be small portable devices designed to bepalm-sized and/or adapted to fit into, for example, a pocket or purse ofa patient. The analyte meter may have the appearance of a personalelectronic device, such as a mobile phone or personal digital assistant(PDA), so that the user may not be identified as a person using amedical device. Additional information is provided in U.S. Pat. No.7,041,468, titled “Blood Glucose Tracking Apparatus and Method” and inU.S. Patent Application Publication No. US2004/0254434, published Dec.16, 2004, titled “Glucose Measuring Module and Insulin PumpCombination”, the disclosures of each of which are incorporated byreference herein.

In embodiments, the analyte meters may be a larger unit for home use anddesigned to sit on a shelf or nightstand. In yet other embodiments, theanalyte meters may be designed for use in a hospital or doctor's office.

Analyte Meter Configured to Receive Analyte Sensor Having an OpposingElectrode Configuration

In one embodiment, as illustrated in FIG. 1, analyte meter 100 includesa housing 105 and a sensor port 101 coupled to the housing 105, whereinthe sensor port 101 is configured to receive an analyte sensor 200 asshown in FIG. 2. Sensor port 101 includes a first electrode contact 103and a second electrode contact 104 positioned on opposing faces ofsensor port 101. Although electrode contact 103 is designated as thefirst electrode contact, and electrode contact 104 is designated as thesecond electrode contact, it should be noted that these designations canbe reversed. That is, the electrode contact indicated by referencenumeral 104 can be the first electrode contact, and the electrodecontact indicated by reference numeral 103 can be the second electrodecontact.

Each of the first electrode contact 103 and the second electrode contact104 is capable of being configured as a working electrode contact.Analyte meter 100 is configured to detect an insertion orientation ofanalyte sensor 200 upon insertion of analyte sensor 200 into sensor port101. Based on the detected insertion orientation, analyte meter 100configures one of first electrode contact 103 and second electrodecontact 104 as a working electrode contact. As described in greaterdetail below, this capability of the analyte meter allows the user ofthe analyte meter to insert an analyte sensor in either of two effectiveinsertion orientations.

In order to facilitate detection of the insertion orientation of analytesensor 200, sensor port 101 can optionally be configured to include afirst turn-on/selection contact 102A and a second turn-on/selectioncontact 102B. In the embodiment shown in FIG. 1, these optionalturn-on/selection contacts are positioned on opposing faces of sensorport 101, although additional configurations are possible. In oneembodiment, as shown in FIG. 1, each of turn-on/selection contacts 102Aand 102B includes a pair of conductive strips. This configuration ismerely exemplary, and many other configurations including singleturn-on/selection contacts are feasible.

In one embodiment, each of first electrode contact 103 and secondelectrode contact 104 is capable of being configured as a referenceand/or counter electrode contact. In such an embodiment, the analytemeter configures one of the electrode contacts as a working electrodecontact (e.g., 103) and the other (e.g., 104) as a reference and/orcounter electrode contact based on the insertion orientation of theanalyte sensor.

In one embodiment, when analyte meter 100 includes optionalturn-on/selection contacts 102A and 102B, analyte meter 100 is activatedfor testing by contacting first turn-on/selection contact 102A or secondturn-on/selection contact 102B with analyte sensor 200 upon insertion ofanalyte sensor 200 into sensor port 101. Analyte meter 100 configuresone of first electrode contact 103 and second electrode contact 104 as aworking electrode contact and one of first electrode contact 103 andsecond electrode contact 104 as a reference and/or counter electrodecontact based on the contacting of first turn-on/selection contact 102Aor second turn-on/selection contact 102B with analyte sensor 200. Thisallows analyte meter 100 to accept an analyte sensor 200 in either a“face-up” or “face-down” orientation. For example, with reference toFIGS. 1 and 2, analyte sensor 200 can be inserted into sensor port 101such that working electrode 203 contacts first electrode contact 103. Inthis orientation, reference and/or counter electrode 204 contacts secondelectrode contact 104. This insertion orientation is considered aface-up orientation. In a face-down orientation, analyte sensor 200 isinserted such that working electrode 203 contacts second electrodecontact 104 and reference and/or counter electrode 204 contacts firstelectrode contact 103.

FIG. 3 illustrates an embodiment of analyte meter 100, wherein analytemeter 100 is configured to receive an analyte sensor using afour-electrode system having opposing working and reference and/orcounter electrodes. Analyte sensors of this type are available fromAbbott Diabetes Care Inc., Alameda, Calif. and include FreeStyle® andFreeStyle Lite™ test strips.

As shown in FIG. 3, in one embodiment, an analyte meter 100 according tothe present disclosure includes a first set of electrode contacts,including electrode contacts 103A, 103B and 103C; and a second set ofelectrode contacts, including 104A, 104B and 104C. At least one ofelectrode contacts 103A, 103B and 103C is capable of being configured asa working electrode contact and at least one of electrode contacts 104A,104B and 104C is capable of being configured as a working electrodecontact.

The analyte meter 100 shown in FIG. 3 is configured to receive ananalyte sensor such as analyte sensor 200 shown in FIG. 4. In order tofacilitate detection of the insertion orientation of analyte sensor 200,sensor port 101 can optionally be configured to include a firstturn-on/selection contact 102A and a second turn-on/selection contact102B. In the embodiment shown in FIG. 3, these optionalturn-on/selection contacts are positioned on opposing faces of sensorport 101, although additional configurations are possible. In oneembodiment, as shown in FIG. 3, each of turn-on/selection contacts 102Aand 102B includes a pair of conductive strips. As indicated above forFIG. 1, this configuration is merely exemplary, and many otherconfigurations including single turn-on/selection contacts are feasible.

In one embodiment, when analyte meter 100 includes optionalturn-on/selection contacts 102A and 102B, analyte meter 100 is activatedfor testing by contacting first turn-on/selection contact 102A or secondturn-on/selection contact 102B with analyte sensor 200 upon insertion ofanalyte sensor 200 into sensor port 101. As in FIG. 1, the analyte meter100 shown in FIG. 3 is capable receiving analyte sensor 200 in a“face-up” or “face-down” insertion orientation. For example, withreference to FIGS. 3 and 4, analyte sensor 200 can be inserted intosensor port 101 such that working electrode 203 contacts electrodecontact 103A. In this orientation, reference and/or counter electrode204 contacts electrode contact 104B and indicator electrodes 208 and 209contact electrode contacts 104A and 104C respectively. This insertionorientation is considered a face-up orientation. In such an orientation,electrode contacts 103C and 103B are inactive. In a face-downorientation, analyte sensor 200 is inserted such that working electrode203 contacts electrode contact 104A. In this orientation, referenceand/or counter electrode 204 contacts electrode contact 103B andindicator electrodes 208 and 209 contact electrode contacts 103A and103C respectively. In such an orientation, electrode contacts 104B and104C are inactive.

In the embodiment shown in FIG. 3, a first set of electrode contacts(103A-103C) are offset relative to a second set of electrode contacts(104A-104C) on opposing faces of sensor port 101. In another embodiment,as shown in FIG. 5, an analyte meter 100 includes a sensor port 101which includes a first set of contacts (103A-103D) positioned directlyacross from a second set of electrode contacts (104A-104D) on opposingfaces of sensor port 101. As indicated above, a sensor 200 as shown inFIG. 4 can be effectively inserted in either of two insertionorientations into an analyte meter 100 as shown in FIG. 3. An analytemeter 200 as shown in FIG. 4 can also be effectively inserted in eitherof two insertion orientations into an analyte meter 100 as shown in FIG.5. In such an embodiment, in a face-up orientation, working electrode203 contacts electrode contact 103A, reference and/or counter electrode204 contacts electrode contact 104B, indicator electrodes 208 and 209contact electrode contacts 104A and 104C respectively, and electrodecontacts 103B, 103C, 103D and 104D are inactive. In a face-downorientation, working electrode 203 contacts electrode contact 104A,reference and/or counter electrode 204 contacts electrode contact 103B,indicator electrodes 208 and 209 contact electrode contacts 103A and103C respectively, and electrode contacts 103D, 104B, 104C and 104D areinactive.

Analyte Meter Configured to Receive Analyte Sensor Having a CoplanarElectrode Configuration

The embodiments described above are directed to analyte metersconfigured to receive analyte sensors having a working electrodepositioned in opposition to a reference and/or counter electrode, e.g.,as shown in FIGS. 2 and 4. In another embodiment, analyte metersaccording to the present disclosure are configured to receive analytesensors having a working electrode and a reference and/or counterelectrode positioned in a coplanar configuration. An example of such acoplanar configuration is provided in FIG. 6, wherein electrodes 203,204, 208 and 209 are positioned in the same lateral plane on substrate201.

The analyte meter 100 shown in FIG. 5 is configured to receive ananalyte sensor such as analyte sensor 200 shown in FIG. 6. In order tofacilitate detection of the insertion orientation of analyte sensor 200,sensor port 101 can optionally be configured to include a firstturn-on/selection contact 102A and a second turn-on/selection contact102B. In the embodiment shown in FIG. 5, these optionalturn-on/selection contacts are positioned on opposing faces of sensorport 101, although additional configurations are possible. In oneembodiment, as shown in FIG. 5, each of turn-on/selection contacts 102Aand 102B includes a pair of conductive strips. This configuration ismerely exemplary, and many other configurations including singleturn-on/selection contacts are feasible.

In one embodiment, when analyte meter 100 includes optionalturn-on/selection contacts 102A and 102B, analyte meter 100 is activatedfor testing by contacting first turn-on/selection contact 102A or secondturn-on/selection contact 102B with analyte sensor 200 upon insertion ofanalyte sensor 200 into sensor port 101. As in FIGS. 1 and 3, analytemeter 100 shown in FIG. 5 is capable receiving analyte sensor 200 in a“face-up” or “face-down” insertion orientation. For example, withreference to FIGS. 5 and 6, analyte sensor 200 can be inserted intosensor port 101 such that working electrode 203 contacts electrodecontact 103B. In this orientation, reference and/or counter electrode204 contacts electrode contact 103C and indicator electrodes 208 and 209contact electrode contacts 103A and 103D respectively. This insertionorientation is considered a face-up orientation. In such an orientation,electrode contacts 104A, 104B, 104C and 104D are inactive. In aface-down orientation, analyte sensor 200 is inserted such that workingelectrode 203 contacts electrode contact 104B. In this orientation,reference and/or counter electrode 204 contacts electrode contact 104Cand indicator electrodes 208 and 209 contact electrode contacts 104A and104D respectively. In such an orientation electrode contacts 103A, 103B,103C and 103D are inactive.

An additional example of a coplanar electrode configuration is providedin FIG. 8, wherein electrodes 203, 204, and 212 are positioned in thesame lateral plane on substrate 201.

The analyte meter 100 shown in FIG. 7 is configured to receive ananalyte sensor such as analyte sensor 200 shown in FIG. 8. In order tofacilitate detection of the insertion orientation of analyte sensor 200,sensor port 101 can optionally be configured to include a firstturn-on/selection contact 102A and a second turn-on/selection contact102B. In the embodiment shown in FIG. 7, these optionalturn-on/selection contacts are positioned on opposing faces of sensorport 101, although additional configurations are possible. In oneembodiment, as shown in FIG. 7, each of turn-on/selection contacts 102Aand 102B includes a pair of conductive strips. This configuration ismerely exemplary, and many other configurations including singleturn-on/selection contacts are feasible.

In one embodiment, when analyte meter 100 includes optionalturn-on/selection contacts 102A and 102B, analyte meter 100 is activatedfor testing by contacting first turn-on/selection contact 102A or secondturn-on/selection contact 102B with analyte sensor 200 upon insertion ofanalyte sensor 200 into sensor port 101. As in FIGS. 1, 3, and 5 analytemeter 100 shown in FIG. 7 is capable receiving analyte sensor 200 in a“face-up” or “face-down” insertion orientation. For example, withreference to FIGS. 7 and 8, analyte sensor 200 can be inserted intosensor port 101 such that working electrode 203 contacts electrodecontact 103C. In this orientation, reference and/or counter electrode204 contacts electrode contact 103A and indicator electrode 212 contactselectrode contact 103B. This insertion orientation is considered aface-up orientation. In such an orientation, electrode contacts 104A,104B, and 104C are inactive. In a face-down orientation, analyte sensor200 is inserted such that working electrode 203 contacts electrodecontact 104C. In this orientation, reference and/or counter electrode204 contacts electrode contact 104A and indicator electrode 212 contactselectrode contact 104B. In such an orientation electrode contacts 103A,103B, and 103C are inactive.

Additional sensors having coplanar electrode configurations aredescribed in U.S. patent application Ser. No. 12/102,374, filed Apr. 14,2008, and U.S. Patent Application Publication No. 2009/0095625, thedisclosures of each of which are incorporated by reference herein.

Analyte Sensors

Referring to the Drawings in general and FIGS. 2, 4, 6 and 8 inparticular, the an analyte sensor 200 described herein generallyincludes a first substrate 201, a spacer 205, a second substrate 202, aworking electrode 203, a reference and/or counter electrode orreference/counter electrode 204, and a measurement zone defined at leastin part by working electrode 203, reference and/or counter electrode 204and one or more of substrate 201, substrate 202 and spacer 205. As usedherein, the term “reference and/or counter electrode” refers to anelectrode that functions as a reference electrode, a counter electrodeor a reference/counter electrode. The measurement zone is configuredsuch that when a sample is provided in the measurement zone the sampleis in electrolytic contact with the working electrode 203 and thereference and/or counter electrode and/or reference/counter electrode204. As shown in FIG. 6, analyte sensor 200 generally includes aproximal end 210 for insertion into analyte meter 100 and a distal end211 for receiving a liquid sample.

In certain embodiments, an analyte sensor has a generally rectangularshape, i.e., the sensor's length is greater than its width, althoughother shapes are possible as well. In one embodiment, the analyte sensoris in the form of a strip.

Analyte sensors suitable for use with the analyte meters describedherein can include a plurality of electrodes, e.g., 2, 3, or 4 or moreelectrodes.

In addition to the embodiments specifically disclosed herein, theanalyte meters of the present disclosure can be configured to work witha wide variety of analyte sensors, e.g., those disclosed in U.S. patentapplication Ser. No. 11/461,725, filed Aug. 1, 2006; U.S. PatentApplication Publication No. 2007/0095661; U.S. Patent ApplicationPublication No. 2006/0091006; U.S. Patent Application Publication No.2006/0025662; U.S. Patent Application Publication No. 2008/0267823; U.S.Patent Application Publication No. 2007/0108048; U.S. Patent ApplicationPublication No. 2008/0102441; U.S. Patent Application Publication No.2008/0066305; U.S. Patent Application Publication No. 2007/0199818; U.S.Patent Application Publication No. 2008/0148873; U.S. Patent ApplicationPublication No. 2007/0068807; U.S. Pat. No. 6,616,819; U.S. Pat. No.6,143,164; and U.S. Pat. No. 6,592,745; the disclosures of each of whichare incorporated by reference herein.

Fill Indicator Detection

As discussed previously herein, analyte sensor 200 can include one ormore indicator electrodes. Such indicator electrodes are well known inthe art and can be used to indicate when a measurement zone of analytesensor 200 is filled with sample. Accordingly, in some embodiments,analyte meter 100 is configured to detect a signal from the indicatorelectrode in addition to signals from the working electrode 203 and/orreference and/or counter electrode 204.

Suitable signals for detection include, for example, voltage, current,resistance, impedance, or capacitance between the indicator electrodeand, for example, working electrode 203. Alternatively, the analytemeter 100 can be configured to detect if a value of the signal (e.g.,voltage, current, resistance, impedance, or capacitance) received fromanalyte sensor 200 has been reached indicating that the measurement zoneis filled.

Analyte meter 100 can include a sign (e.g., a visual sign or auditorysignal) that is activated in response to the indicator electrode toalert the user that the measurement zone has been filled. The controllerunit of analyte meter 100 can be configured to initiate a reading whenthe indicator electrode indicates that the measurement zone has beenfilled with or without alerting the user. The reading can be initiated,for example, by applying a potential between the working electrode andthe reference and/or counter electrode and beginning to monitor thesignals generated at the working electrode. Additional description ofindicator electrodes and fill-detection can be found in U.S. Pat. No.6,592,745, the disclosure of which is incorporated by reference herein.

Turn-On/Selection Monitor

In some embodiments, analyte meter 100 is configured to receive ananalyte sensor 200 which includes an optional turn-on/selection monitor206 as shown in FIGS. 2, 4, 6 and 8. The turn-on/selection monitor 206is configured to facilitate certain functions of analyte meter 100. Forexample in one embodiment, turn-on/selection monitor 206 is designed tofacilitate detection of analyte sensor 200 by analyte meter 100 uponinsertion of analyte sensor 200 into sensor port 101. In one embodiment,such detection results in activation of analyte meter 100 for testing,i.e., turn-on/selection monitor 206 facilitates a “turn-on” function ofanalyte meter 100. In another embodiment, such detection results in theanalyte meter selecting a particular electrode contact (e.g. one of twoavailable electrode contacts) as a working electrode contact, i.e.,turn-on/selection monitor 206 facilitates a “selection” function ofanalyte meter 100.

In the context of the embodiment shown in FIGS. 1, 3, 5 and 7, optionalturn-on/selection monitor 206 is designed to contact either firstturn-on/selection contact 102A or second turn-on/selection contact 102Bupon insertion of analyte sensor 200.

In some embodiments, detection of the analyte sensor is accomplishedelectrically. For example, the turn-on/selection monitor 206 can beconfigured to close or open an electrical circuit when the sensor isinserted into the analyte meter. In some embodiments, closing or openingthe electrical circuit in turn activates the analyte meter for testing.The turn-on/selection monitor 206 can include a conductive materialwhich facilitates electronic detection of analyte sensor 200. Forexample, in the embodiment shown in FIGS. 2, 4, 6 and 8,turn-on/selection monitor 206 comprises conductive material is in theform of a conductive strip extending across an exterior surface ofanalyte sensor 200.

In one embodiment, turn-on/selection monitor 206 is designed such thatit physically opens or closes an electric circuit in an analyte meterupon insertion. For example, turn-on/selection monitor 206 could bedesigned as a dimple or a protrusion which physically opens or closes anelectronic circuit upon insertion of the analyte sensor into the analytemeter.

In other embodiments, detection of the analyte sensor is accomplishedmechanically. For example, turn-on/selection monitor 206 can have aphysical structure which engages with a corresponding physical structurein sensor port 101, e.g., in a “lock and key” type configuration. Forexample, turn-on/selection monitor 206 can include a first physicalstructure configured to engage with a second physical structure presentin sensor port 101, wherein the physical structure present on analytesensor 200 includes at least one cutout and/or protrusion, wherein theshape, dimensions and/or number of the at least one cutout and/orprotrusion engages with a corresponding physical structure in sensorport 101. The forming of a particular cutout and/or protrusion shape maybe accomplished by several methods. For example, the specific cutoutand/or protrusion shape may be formed by cutting to a desired shape. Thecutting may be done, by, for example, a laser such as a laser-ablationmethod. The sensor port 101 can be configured such that this physicalinteraction in turn facilitates turn-on and/or selection functions ofthe analyte meter 100 as described above.

While the turn-on/selection contacts of FIGS. 1, 3, 5 and 7 are shown aspairs of conductive strips, it should be noted that a variety ofconfigurations are possible for the turn-on/selection contacts, providedthat, where the turn-on/selection contacts facilitate a selectionfunction of the analyte meter, the analyte meter can determine whichorientation (face-up or face-down) the analyte sensor is in onceinserted and select the electrode contacts accordingly.

In one embodiment, where the analyte meter 100 is designed to receive asensor 200 having a two electrode configuration such as that shown inFIG. 2, one of the electrode contacts is selected as the workingelectrode contact the remaining electrode contact is selected as thereference and/or counter electrode contact based on the insertionorientation of sensor 200.

In one embodiment, insertion of the analyte sensor 200 into a sensorport 101 of analyte meter 100 results in the completion of a circuitwhen the turn-on/selection monitor 206 comes into contact with a pair ofturn-on/selection contacts.

In one particular embodiment, turn-on/selection monitor 206 ispositioned at least substantially perpendicular to working electrode 203and reference and/or counter electrode 204. In another embodiment,turn-on/selection monitor 206 is positioned at least substantiallyparallel to working electrode 203 and reference and/or counter electrode204.

Turn-on/selection monitor 206 may have any suitable configuration,including but not limited to, a stripe extending across analyte sensor200 from a side edge to a side edge, such as the embodiment shown inFIGS. 2, 4, 6 and 8; a stripe extending across the analyte sensor,although not the entire width; and an array of unconnected dots, strips,or other areas. Other suitable configurations for turn-on/selectionmonitor 206 are provided in U.S. Patent Application Publication No.US2006/0091006; U.S. Patent Application Publication No. US2008/0267823;U.S. Pat. No. 6,592,745; U.S. Pat. No. 6,143,164; U.S. Pat. No.6,071,391; U.S. Pat. No. 6,503,381; U.S. Pat. No. 6,616,819 and U.S.Pat. No. 6,893,545; the disclosures of each of which are incorporated byreference herein.

Sensor Port

As described above, analyte meter 100 includes sensor port 101. Itshould be noted that while the figures depict both analyte sensor 200and corresponding sensor port 101 as having a rectangular box shape,such configuration is for exemplary purposes only and a variety of otherconfigurations are possible. For example, a cylindrical configurationcould be used for both analyte sensor 200 and sensor port 101.

In the embodiment shown in FIG. 1, sensor port 101 includes firstelectrode contact 103 and second electrode contact 104. These contactscan be made of the same or different material and any suitable material,e.g., carbon, platinum, etc., can be used provided that the material issufficiently conductive to allow transfer of an electrical signal fromelectrodes 203 and 204 of analyte sensor 200.

A variety of configurations are possible for electrode contacts 103 and104, and these configurations can be modified based on the selectedconfiguration of electrodes 203 and 204 on analyte sensor 200 and viceversa. In one embodiment, electrode contacts 103 and 104 are positioneddirectly across from one another on opposing faces of sensor port 101.In other embodiments, electrode contacts 103 and 104 are not positioneddirectly across from one another, but are instead offset on opposingfaces of sensor port 101. An example of an offset electrode contactconfiguration is shown in FIG. 1. Notwithstanding the above, electrodecontacts 103 and 104 are positioned in the sensor port such that one ofelectrode contacts 103 and 104 contacts working electrode 103 and theother electrode contact contacts reference and/or counter electrode 204upon insertion of analyte sensor 200 into sensor port 101.

Sensor port 101 also includes first turn-on/selection contact 102A andsecond turn-on/selection contact 102B positioned on opposing faces ofsensor port 101. These contacts can be made of the same or differentmaterial and any suitable material can be used. In some embodiments, thematerial is sufficiently conductive to allow for completion of anelectrical circuit when contacted by a conductive turn-on/selectionmonitor.

A variety of configurations are possible for turn-on/selection contacts102A and 102B, and these configurations can be modified based on theselected configuration of turn-on/selection monitor 206 and vice versa.For example, in the embodiments shown in FIGS. 1, 3, 5 and 7, each ofturn-on/selection contacts 102A and 102B is shown as a pair ofconductive strips positioned on the bottom and top faces respectively ofsensor port 101.

Turn-on/selection contacts 102A and 102B can be positioned to suit aparticular sensor/meter configuration. In the embodiments shown in FIGS.1, 3, 5 and 7, turn-on/selection contacts 102A and 102B are positionedsubstantially parallel with insertion path 106 of analyte sensor 200.This orientation can be adjusted, e.g., depending on the orientation ofturn-on/selection monitor 206 on analyte sensor 200. For example, ifturn-on/selection monitor 206 were positioned parallel to electrodes 203and 204 of analyte sensor 200 (rather than perpendicular as shown inFIGS. 2, 4, 6 and 8) it may be desirable to position turn-on/selectioncontacts 102A and 102B substantially perpendicular to insertion path 106in sensor port 101. As indicated above, the configuration provided inFIGS. 1, 3, 5 and 7 is merely exemplary, and many other configurationsincluding single turn-on/selection contacts are feasible.

In some embodiments, analyte meter 100 is configured to detect insertionof analyte sensor 200 mechanically. In such embodiments, firstturn-on/selection contact 102A and second turn-on/selection contact 102Bare configured accordingly. For example, turn-on/selection contacts 102Aand 102B could each be designed as a pair of conductive strips, whereinthe members of each pair are in contact and part of a closed electricalcircuit when analyte sensor 200 is not inserted. The members of eachpair can be configured such that their contact is physically disruptableupon insertion of an analyte sensor 200 having a turn-on/selectionmonitor 206 with a specific physical structure, e.g. a raised protrusionwhich physically separates a member of each pair of conductive stripsfrom the other member of the pair of conductive strips. In this manner,one of turn-on/selection contacts 102A and 102B will be contacted andthe analyte meter 100 can select a particular electrode contact as theworking electrode contact accordingly.

In some embodiments, analyte meter 100 is configured to detect insertionof analyte sensor 200 optically. In such embodiments, firstturn-on/selection contact 102A and second turn-on/selection contact 102Bare configured accordingly. For example, turn-on/selection contacts 102Aand 102B could each be configured to include a photodetector, whereinthe photodetector is configured to detect a colored area on a face ofthe sensor. Depending on the insertion orientation, one ofturn-on/selection contacts 102A and 102B will detect the colored areaand the analyte meter 100 can select a particular electrode contact asthe working electrode contact accordingly. A variety of photodetectorsare known in the art, including but not limited to photoconductivecells, photodiodes, photoresistors, photoswitches, phototransistors,phototubes, and photovoltaic cells. It is also contemplated that opticalmeans could be utilized to detect a physical structure present onanalyte sensor 200, e.g., a particular shape and/or arrangement ofcutouts and/or protrusions present on analyte sensor 200, and thatinsertion orientation could be detected accordingly.

In one embodiment, analyte meter 100 includes an optional illuminationdevice, e.g., a light emitting diode (LED), which may be configured toilluminate the sensor port 101 during the analyte sensor insertionprocess to assist the user in properly and accurately inserting theanalyte sensor 200 into sensor port 101. In some embodiments, theoptional illumination device facilitates the optical detection ofanalyte sensor insertion orientation.

In a further embodiment of the present disclosure, the sensor port 101may be configured with a physical latch or securement mechanism suchthat when the analyte sensor 200 is inserted into the sensor port 101,the analyte sensor 200 is retained in the received position within thesensor port 101 until the sample analysis is completed. Examples of suchphysical latch or securement mechanism may include a uni-directionallybiased anchor mechanism, or a pressure application mechanism to retainthe analyte sensor 200 in place by applying pressure on one or moresurfaces of the analyte sensor 200 within the sensor port 101.Additional information is provided in U.S. Patent ApplicationPublication No. 2008/0119709, the disclosure of which is incorporated byreference herein.

Controller Unit

Analyte meter 100 also includes a controller unit (not shown) coupled tohousing 105, wherein the controller unit is configured to process asignal received from analyte sensor 200 and determine the presenceand/or concentration of the analyte based on the signal.

The controller unit is configured to process a signal received fromanalyte sensor 200 and determine a concentration of analyte, e.g.,glucose, based on the signal. Details relating to the receipt of ananalyte signal from an analyte sensor and the determination of aconcentration of analyte are described, for example, in U.S. Pat. No.7,041,468; U.S. Pat. No. 5,356,786; U.S. Pat. No. 6,175,752; U.S. Pat.No. 6,560,471; U.S. Pat. No. 5,262,035; U.S. Pat. No. 6,881,551; U.S.Pat. No. 6,121,009; U.S. Pat. No. 7,167,818; U.S. Pat. No. 6,270,455;U.S. Pat. No. 6,161,095; U.S. Pat. No. 5,918,603; U.S. Pat. No.6,144,837; U.S. Pat. No. 5,601,435; U.S. Pat. No. 5,822,715; U.S. Pat.No. 5,899,855; U.S. Pat. No. 6,071,391; U.S. Pat. No. 6,120,676; U.S.Pat. No. 6,143,164; U.S. Pat. No. 6,299,757; U.S. Pat. No. 6,338,790;U.S. Pat. No. 6,377,894; U.S. Pat. No. 6,600,997; U.S. Pat. No.6,773,671; U.S. Pat. No. 6,514,460; U.S. Pat. No. 6,592,745; U.S. Pat.No. 5,628,890; U.S. Pat. No. 5,820,551; U.S. Pat. No. 6,736,957; U.S.Pat. No. 4,545,382; U.S. Pat. No. 4,711,245; U.S. Pat. No. 5,509,410;U.S. Pat. No. 6,540,891; U.S. Pat. No. 6,730,200; U.S. Pat. No.6,764,581; U.S. Pat. No. 6,299,757; U.S. Pat. No. 6,461,496; U.S. Pat.No. 6,503,381; U.S. Pat. No. 6,591,125; U.S. Pat. No. 6,616,819; U.S.Pat. No. 6,618,934; U.S. Pat. No. 6,676,816; U.S. Pat. No. 6,749,740;U.S. Pat. No. 6,893,545; U.S. Pat. No. 6,942,518; U.S. Pat. No.6,514,718; U.S. Pat. No. 5,264,014; U.S. Pat. No. 5,262,305; U.S. Pat.No. 5,320,715; U.S. Pat. No. 5,593,852; U.S. Pat. No. 6,746,582; U.S.Pat. No. 6,284,478; U.S. Pat. No. 7,299,082; U.S. patent applicationSer. No. 10/745,878 filed Dec. 26, 2003 entitled “Continuous GlucoseMonitoring System and Methods of Use”; U.S. Patent Application No.61/149,639 entitled “Compact On-Body Physiological Monitoring Device andMethods Thereof”, U.S. patent application Ser. No. 11/461,725, filedAug. 1, 2006; U.S. Patent Application Publication No. 2007/0095661; U.S.Patent Application Publication No. 2006/0091006; U.S. Patent ApplicationPublication No. 2006/0025662; U.S. Patent Application Publication No.2008/0267823; U.S. Patent Application Publication No. 2007/0108048; U.S.Patent Application Publication No. 2008/0102441; U.S. Patent ApplicationPublication No. 2008/0066305; U.S. Patent Application Publication No.2007/0199818; U.S. Patent Application Publication No. 2008/0148873; andU.S. Patent Application Publication No. 2007/0068807; the disclosures ofeach which are incorporated by reference herein.

In some embodiments, the analyte meter 100 includes a data storage unit(not shown) operably connected to the controller unit, e.g., asdescribed in U.S. patent application Ser. No. 11/396,182, filed Mar. 31,2006, titled “Analyte Monitoring Devices and Methods Therefor,” thedisclosure of which is incorporated by reference herein.

Dosage Calculation Function

In some embodiments, the controller unit is configured to performmedication dosage calculation functions, such as a single-dosecalculation function for injection of rapid acting insulin and/or longacting insulin. Analyte meters which include medication dosagecalculation functions and methods of performing the dosage calculationfunctions are described, for example, in U.S. patent application Ser.No. 11/396,182, filed Mar. 31, 2006, titled “Analyte Monitoring Devicesand Methods Therefor,” the disclosure of which is incorporated byreference herein.

In one embodiment, the controller unit is configured to perform a boluscalculation function. For example, the controller unit may be configuredto determine a bolus dosage, e.g., an insulin bolus dosage, based on thesignal received from the analyte sensor.

In one embodiment the controller unit is configured to perform analgorithm to determine a medication dosage based on a determinedconcentration of analyte.

The analyte meter 100 may be configured to automatically enter into amedication dosage calculation mode to, for example, calculate and/orselect a medication dosage amount based on information stored in theanalyte meter 100 (such as the patient's insulin sensitivity, forexample), and/or prompt the patient to provide additional information,such as the amount of carbohydrate to be ingested by the patient fordetermination of, for example, a carbohydrate bolus dosagedetermination. The patient may operate the input unit 107 (described ingreater below) to provide the appropriate information.

In another embodiment, the analyte meter 100 may be configured to promptthe patient to select whether to retrieve a predetermined orpreprogrammed medication dosage amount such as, for example, acorrection bolus or a carbohydrate bolus, following the display of thedetermined analyte concentration from the analyte sensor 200. In thismanner, in one embodiment of the present disclosure, analyte meter 100may be configured to automatically prompt the user or patient to selectwhether a medication dosage determination is desired following analytetesting using the analyte sensor 200.

FIG. 10 provides a flowchart illustrating an analyte concentrationdetermination and medication dose calculation procedure in accordancewith one embodiment of the present disclosure. Referring to FIG. 10 andFIGS. 1-8, an analyte sensor 200 is detected by the analyte meter 100(510). Thereafter, the fluid sample, such as a blood sample, present inthe measurement zone of analyte sensor 200 is analyzed (520) todetermine the corresponding analyte level, such as a glucose level, andthe determined analyte level is output (530) on the optional displayunit 108 of analyte meter 100, for example, in units of mg/dL.

After determining the analyte level and displaying the measured analytelevel to the patient (530), a prompt command is generated and output tothe patient to select if the medication dosage calculation is desired(540). More specifically, in one embodiment of the present disclosure,the controller unit is configured to generate a command and display inthe optional display unit 108 to query the user as to whether amedication dosage calculation determination is desired by the patient.Thereafter, a determination of whether or not the patient has selectedto have the medication dosage calculation performed by the controllerunit is made (550). In one embodiment, the patient may operate theoptional input unit 107 to select whether or not to have the medicationdosage calculation performed.

If it is determined that the patient has selected not to have themedication dosage determination performed, then the determined analytevalue is displayed and/or stored (560), e.g., in an optional datastorage unit of analyte meter 100, and the routine terminates. Forexample, in one embodiment, the controller unit may be configured tostore the determined analyte value in the optional data storage unitwith associated time and/or date information of when the analyte valuedetermination is performed. In an alternate embodiment, the measuredanalyte value may be stored substantially concurrently with the displayof the analyte value.

On the other hand, if it is determined that the patient has selected tohave the medication dosage calculation performed, the analyte meter 100is configured to enter the medication dosage determination mode (570),described in further detail below in conjunction with FIG. 11, where thedesired type of medication dosage is determined and provided to thepatient.

FIG. 11 is a flowchart illustrating the medication dose calculationprocedure of FIG. 10 in accordance with one embodiment of the presentdisclosure. Referring to FIG. 11 and FIGS. 1-8, when the analyte meter100 enters the medication dosage determination mode as described above,the controller unit is configured to prompt the patient (for example, bydisplaying the options to the patient on the optional display unit 108to select the type of desired medication dosage calculation (610). Forexample, the controller unit may be configured to output a list ofavailable medication dosage calculation options including, for example,bolus calculation options such as a carbohydrate bolus, a correctionbolus, a dual or extended bolus, a square wave bolus, or any othersuitable medication calculation function which may be programmed intothe analyte meter 100 (and for example, stored in the optional datastorage unit).

After the patient selects the desired medication dosage calculation inresponse to the prompt for medication type selection (610), the selectedmedication dosage calculation routine is retrieved (620) from theoptional data storage unit, and thereafter executed (630). In oneembodiment, the execution of the selected medication dosage calculation(630) may include one or more input prompts to the patient to enteradditional information as may be required to perform the selectedmedication dosage calculation.

For example, in the case of calculating a carbohydrate bolus, thepatient may be prompted to provide or enter an estimate of thecarbohydrate amount that the patient is planning on ingesting. In thisregard, a food database may be stored in the optional data storage unitor elsewhere for easy access (e.g., a PC, PDA, telephone, or the likeand to which the analyte monitor may be coupled (e.g., wirelessly or byphysical connection) to easily retrieve such information) toconveniently determine the corresponding carbohydrate amount associatedwith the type of food which the patient will be ingesting.Alternatively, the patient may provide the actual estimated carbohydratecount if such information is readily available by the patient.

In the case of calculating a dual bolus of insulin, the patient isprompted to provide, in addition to a dose amount, a time durationinformation for the extended portion of the bolus dosage to be infusedor otherwise delivered to the patient. Similarly, the patient mayfurther be prompted to provide insulin sensitivity information, and anyother information as may be necessary to determine the selected bolusdosage amount in conjunction with other relevant information such asinsulin on board information, and the time of the most recentlyadministered bolus (so as to provide a warning to the patient if a bolusdosage has been administered within a predetermined time period, and asubsequent administration of the additional bolus dosage may potentiallybe harmful).

After the execution of the selected medication dosage calculationroutine (630), the calculated medication dosage amount is stored (640)in the optional data storage unit, and the calculated medication dosageamount is output displayed to the patient (650) on the display unit 108of the analyte meter 100, or audibly if the analyte meter is soconfigured. In certain embodiments, storing and output displaying thecalculated medication dosage amount may be substantially concurrentlyperformed, rather than sequentially.

FIG. 12 is a flowchart illustrating an analyte level determination andmedication dose calculation procedure in accordance with anotherembodiment of the present disclosure. An analyte sensor 200 is insertedinto the sensor port 101 of analyte meter 100 (710), the fluid sample inthe measurement zone of analyte sensor 200 is analyzed to determine thecorresponding analyte concentration (720), and thereafter, outputdisplayed (730).

The controller unit is configured to enter into the medication dosagedetermination mode, retrieve a programmed or predetermined boluscalculation routine (740), execute the pre-programmed or predeterminedbolus calculation routine (750), and thereafter, output display thecalculated medication dosage amount (760). In this manner, in oneembodiment of the present disclosure, the analyte meter 100 may beprogrammed or configured to automatically enter into the medicationdosage determination mode upon completion of the fluid sample analysisfor analyte level determination.

In one embodiment of the present disclosure, the analyte meter 100 maybe configured to execute different types of medication dosagecalculations based on the patient specified parameters. For example, theanalyte meter 100 may be configured to perform a carbohydrate bolusdetermination when the analyte sensor sample analysis is performedwithin a predetermined time period of a meal event. For example, theanalyte meter 100 may be programmed by the patient to automaticallyselect the carbohydrate bolus determination if the analyte sensor fluidsample analysis is performed within one hour prior to a meal time (whichmay be programmed into the analyte meter 100).

Integrated Medication Delivery System

In some embodiments, analyte meter 100 includes an optional medicationdelivery device or system (not shown). Additional information regardingmedication delivery devices or systems, such as, for example, integratedsystems, are provided, for example, in U.S. Patent ApplicationPublication No. US2006/0224141, published on Oct. 5, 2006, titled“Method and System for Providing Integrated Medication Infusion andAnalyte Monitoring System”, and U.S. Patent Application Publication No.US2004/0254434, published on Dec. 16, 2004, titled “Glucose MeasuringModule and Insulin Pump Combination,” the disclosure of each of which isincorporated by reference herein. Medication delivery devices which maybe provided with analyte meter 100 include, e.g., a needle, syringe,pump, catheter, inhaler, transdermal patch, or combination thereof.

The medication delivery device or system may be in the form of a drugdelivery injection pen such as a pen-type injection device incorporatedwithin housing 105 of analyte meter 100. Additional information isprovided in U.S. Pat. Nos. 5,536,249 and 5,925,021, the disclosure ofeach of which is incorporated by reference herein.

The medication delivery system may be used for injecting a dose ofmedication, such as insulin, into a patient based on a prescribedmedication dosage, and may be automatically updated with dosageinformation received from the controller unit (not shown) of analytemeter 100. In another embodiment, the medication dosage of themedication delivery system may include manual entry of dosage changesmade through, for example, optional input unit 107 coupled to thehousing of analyte meter 100. Medication dosage information associatedwith the medication delivery system may be displayed on an optionaldisplay unit disposed on housing 105 of analyte meter 100.

Analyte Detection Systems

An analyte meter 100 as described herein can be a component of one ormore analyte detections systems. For example, an analyte detectionsystem according to the present disclosure can include an analyte meter100 as described herein in addition to one or more sample acquisitionand/or testing elements known in the art. In one embodiment, an analytedetection system according to the present disclosure includes an analytesensor, e.g., an analyte sensor 200 as described herein, and a lancet.In some embodiments, the analyte sensor 200 is in the form of a teststrip.

In some embodiments, a lancet and an analyte sensor 200 in the form of atest strip are integrated into the housing of the analyte meter 100. Inspecific embodiments, a plurality of analyte sensors and a plurality oflancets are integrated into the housing of an analyte meter 100. Inother embodiments, the lancet and the test strip are not integrated intothe housing of the analyte meter, but are instead included in the systemas separate components.

Where the test strip is integrated into the housing of an analyte meter100, the housing can be configured to hold one or more cartridges ormagazines containing test strips to be used in the operation of thesystem. Similarly, where the lancet is integrated into the housing of ananalyte meter 100, the housing can be configured to hold one or morecartridges or magazine containing lancets to be used in the operation ofthe system.

Additional systems incorporating the analyte meters described hereinwill be readily apparent to those of ordinary skill in the art uponreading the present disclosure.

Integrated Monitoring Device

In one embodiment, the analyte meter 100 incorporates an optionalcontinuous analyte monitoring device, e.g., a continuous glucosemonitoring device (CGM). The continuous analyte monitoring device canbe, e.g., a transcutaneously implanted sensor which continually orsubstantially continually measures an analyte concentration of a bodilyfluid. Examples of continuous analyte monitoring systems and devices aredescribed in U.S. Pat. No. 5,356,786; U.S. Pat. No. 6,175,752; U.S. Pat.No. 6,560,471; U.S. Pat. No. 5,262,035; U.S. Pat. No. 6,881,551; U.S.Pat. No. 6,121,009; U.S. Pat. No. 7,167,818; U.S. Pat. No. 6,270,455;U.S. Pat. No. 6,161,095; U.S. Pat. No. 5,918,603; U.S. Pat. No.6,144,837; U.S. Pat. No. 5,601,435; U.S. Pat. No. 5,822,715; U.S. Pat.No. 5,899,855; U.S. Pat. No. 6,071,391; U.S. Pat. No. 6,120,676; U.S.Pat. No. 6,143,164; U.S. Pat. No. 6,299,757; U.S. Pat. No. 6,338,790;U.S. Pat. No. 6,377,894; U.S. Pat. No. 6,600,997; U.S. Pat. No.6,773,671; U.S. Pat. No. 6,514,460; U.S. Pat. No. 6,592,745; U.S. Pat.No. 5,628,890; U.S. Pat. No. 5,820,551; U.S. Pat. No. 6,736,957; U.S.Pat. No. 4,545,382; U.S. Pat. No. 4,711,245; U.S. Pat. No. 5,509,410;U.S. Pat. No. 6,540,891; U.S. Pat. No. 6,730,200; U.S. Pat. No.6,764,581; U.S. Pat. No. 6,299,757; U.S. Pat. No. 6,461,496; U.S. Pat.No. 6,503,381; U.S. Pat. No. 6,591,125; U.S. Pat. No. 6,616,819; U.S.Pat. No. 6,618,934; U.S. Pat. No. 6,676,816; U.S. Pat. No. 6,749,740;U.S. Pat. No. 6,893,545; U.S. Pat. No. 6,942,518; U.S. Pat. No.6,514,718; U.S. Pat. No. 5,264,014; U.S. Pat. No. 5,262,305; U.S. Pat.No. 5,320,715; U.S. Pat. No. 5,593,852; U.S. Pat. No. 6,746,582; U.S.Pat. No. 6,284,478; U.S. Pat. No. 7,299,082; U.S. patent applicationSer. No. 10/745,878 filed Dec. 26, 2003 entitled “Continuous GlucoseMonitoring System and Methods of Use”; and U.S. Application No.61/149,639 entitled “Compact On-Body Physiological Monitoring Device andMethods Thereof”, the disclosures of each which are incorporated byreference herein.

Communication Device

In some embodiments, the analyte meter 100 includes an optionalcommunication device (not shown), e.g., a receiver and/or transmitterfor communicating with another device, e.g., a medication deliverydevice and/or a patient monitoring device, e.g., a continuous glucosemonitoring device as described above, or a health management system,such as the CoPilot™ system available from Abbott Diabetes Care Inc.,Alameda, Calif. The communication device can be configured for wired orwireless communication, including, but not limited to, radio frequency(RF) communication, Zigbee communication protocols, WiFi, Bluetoothcommunication protocols, and cellular communication, such as codedivision multiple access (CDMA) or Global System for Mobilecommunications (GSM).

In one embodiment, analyte meter 100 includes a wireless communicationdevice, wherein the wireless communication device is configured forbi-directional radio frequency (RF) communication with other devices totransmit and/or receive data to and from the analyte meter 100.

In one embodiment, the communication device is configured to includephysical ports or interfaces such as a USB port, an RS-232 port, or anyother suitable electrical connection port to allow data communicationbetween the analyte meter 100 and other external devices such as acomputer terminal (for example, at a physician's office or in hospitalenvironment), an external medical device, such as an infusion device orincluding an insulin delivery device, or other devices that areconfigured for similar complementary data communication.

In one embodiment, the communication device is configured for infraredcommunication, Bluetooth communication, or any other suitable wirelesscommunication mechanism to enable the analyte meter 100 forcommunication with other devices such as infusion devices, analytemonitoring devices, computer terminals and/or networks, communicationenabled mobile telephones, personal digital assistants, or any othercommunication devices which the patient or user of the analyte meter mayuse in conjunction therewith, in managing the treatment of a healthcondition, such as diabetes.

In one embodiment, the analyte meter is configured to wirelesslycommunicate with a server device, e.g., using a common standard such as802.11 or Bluetooth RF protocol, or an IrDA infrared protocol. Theserver device could be another portable device, such as a PersonalDigital Assistant (PDA) or notebook computer, or a larger device such asa desktop computer, appliance, etc. In some embodiments, the serverdevice has a display, such as a liquid crystal display (LCD), as well asan input device, such as buttons, a keyboard, mouse or touch-screen.With such an arrangement, the user can control the meter indirectly byinteracting with the user interface(s) of the server device, which inturn interacts with the meter across a wireless link.

Input Unit

In some embodiments, analyte meter 100 includes an optional input unit107 coupled to the housing 105. The input unit can be configured toinclude one or more input buttons (as shown in FIGS. 1, 3, 5 and 7), ajog wheel, capacitive sensing slider inputs, or combinations thereof. Inone embodiment, a user or patient can operate the input unit to performcalculations and determinations associated with one or more medicationdose calculation functions, such as a bolus dose calculation function,of the analyte meter 100.

In one embodiment, the input unit includes a plurality of input buttons,wherein each input button is designated for a specific task.Alternatively, one or more of the input buttons can be “soft buttons”.In the case where one or more of the plurality of input buttons are“soft buttons”, these buttons may be used for a variety of functions.The variety of functions may be determined based on the current mode ofthe analyte meter 100, and may be distinguishable to a user by the useof button instructions shown on optional display unit 108 of analytemeter 100. Yet another input method may be a touch-sensitive displayunit, as described in greater detail below.

In addition, in some embodiments, the input unit 107 is configured suchthat a user can operate input unit 107 to adjust time and/or dateinformation, as well as other features or settings associated with theoperation of analyte meter 100.

Display

In some embodiments, the analyte meter 100 includes an optional displayunit 108 or a port (not shown) for coupling an optional display unit tothe analyte meter 100. The display unit displays the sensor signalsand/or results determined from the sensor signals including, forexample, analyte concentration, rate of change of analyte concentration,and/or the exceeding of a threshold analyte concentration (indicating,for example, hypo- or hyperglycemia).

The display unit 108 can be a dot-matrix display. In other embodiments,other display types, such as liquid-crystal displays (LCD), plasmadisplays, light-emitting diode (LED) displays, or seven-segmentdisplays, among others, may alternatively be used. The display unit 108can be configured to provide, an alphanumeric display, a graphicaldisplay, a video display, an audio display, a vibratory output, orcombinations thereof. The display unit can also be configured toprovide, for example, information related to a patient's current analyteconcentration as well as predictive analyte concentrations, such astrending information.

In some embodiments the input unit 107 and the display unit 108 areintegrated into a single unit, for example, the display unit 108 can beconfigured as a touch sensitive display where the patient may enterinformation or commands via the display area using, for example, astylus or any other suitable input device, and where, the touchsensitive display is configured as the user interface in an icon drivenenvironment, for example.

Additional Functional Units

A variety of analyte meters are known in the art, many of which includesadditional components and functionalities which can be readilyincorporated into the analyte meters described herein. Disclosure ofsuch additional components and functionalities can be found, forexample, in U.S. Patent Application Publication No. 2008/0119702, U.S.Patent Application Publication No. US 2008/0114280, and U.S. PatentApplication Publication No. 2008/0119710, the disclosure of each ofwhich is incorporated by reference herein.

Demarcation

In one embodiment, an analyte meter according to the present disclosureincludes a demarcation that corresponds with a complementary demarcationon an analyte sensor configured to be received by the analyte meter. Theuse of complementary demarcations on the analyte sensor and meterfacilitate insertion of the analyte sensor into the meter in aparticular orientation, e.g., a correct orientation. In other words,enables correct registration between an analyte sensor and a meter. Acorrect orientation is one in which the analyte meter is capable ofreceiving a sensor signal from the analyte sensor, which signal isindicative of an analyte concentration.

Suitable demarcations include, e.g., colored areas, visible designs orpatterns, patterns of indentations, patterns of raised areas, orcombinations thereof. The demarcation on the analyte sensor can be thesame as a demarcation on the analyte meter. By way of example, FIG. 9,panel A, illustrates an embodiment wherein the top surface of analytesensor 200 comprises a checkerboard pattern which corresponds to amatching checkerboard pattern present on analyte meter 100. FIG. 9,panel B, illustrates a further embodiment in which analyte sensor 200and analyte meter 100 have a matching pattern of vertical lines inaddition to matching checkerboard patterns.

Corresponding demarcations need not be matching. However, they areconfigured to convey an insertion orientation to the user. FIG. 9, panelC, for example, shows corresponding arrow designs which are similarexcept that they point in opposite directions when the analyte sensor isinserted in the intended orientation.

In some embodiments, the analyte sensor includes a first demarcationwhich includes a first portion of a design or logo, and the analytemeter includes a second demarcation comprising a second portion of thedesign, such that the first portion of the design mates with the secondportion of the design to produce the design when the sensor is correctlyinserted into the analyte meter.

Analytes

A variety of analytes can be detected and quantified using the disclosedanalyte sensors and meters. Analytes of particular interest includeglucose and lactate. Additional analytes that may be determined include,for example, acetyl choline, amylase, bilirubin, cholesterol, chorionicgonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA,fructosamine, glucose, glutamine, growth hormones, hormones, ketones(e.g., ketone bodies), lactate, oxygen, peroxide, prostate-specificantigen, prothrombin, RNA, thyroid stimulating hormone, and troponin.The concentration of drugs, such as, for example, antibiotics (e.g.,gentamicin, vancomycin, and the like), digitoxin, digoxin, drugs ofabuse, theophylline, and warfarin, may also be determined. Assayssuitable for determining the concentration of DNA and/or RNA aredisclosed in U.S. Pat. No. 6,281,006 and U.S. Pat. No. 6,638,716, thedisclosures of each of which are incorporated by reference herein.

Methods of Using Analyte Meter

The analyte meters described herein find use in methods for determiningthe concentration of an analyte in a fluid sample from a subject.Generally, these methods include inserting an analyte sensor into ananalyte meter 100; contacting a fluid sample e.g. a blood sample, withthe analyte sensor; generating a sensor signal at the working electrode;and determining the concentration of the analyte using the generatedsensor signal. Examples of specific electrochemical reactions which canbe utilized to produce a sensor signal are described in detail in U.S.Pat. No. 6,592,745, the disclosure of which is incorporated by referenceherein.

In one embodiment, the analyte sensor is an analyte sensor 200 asdescribed herein. However, it is contemplated that analyte sensors otherthan those specifically described herein may be configured to operatewith the analyte meters 100 disclosed herein. Furthermore, analytemeters can be configured as described herein to be compatible with avariety of analyte sensors.

In one embodiment, the determining step includes determining theconcentration of the analyte by amperometry, coulometry, potentiometry,and/or voltametry, including square wave voltametry, using the analytesensor.

In one embodiment, the determining step includes determining theconcentration of the analyte optically. Optical detection of analyteconcentration is described, for example, in U.S. Pat. No. 6,592,745, thedisclosure of which is incorporated by reference herein.

In one embodiment, the method includes a medication dosage determinationstep. For example, where the analyte is glucose, the method can includea determination step in which the controller unit performs an algorithmto determine an insulin dose, e.g., a bolus insulin dose, based on theconcentration of glucose in the sample.

In another embodiment, the method includes an administering step whereina medication dose, e.g., an insulin dose, determined according to themethod is administered to the subject via a medication delivery device,e.g., a needle, syringe, pump, catheter, inhaler, transdermal patch, orcombination thereof.

In another embodiment, the administering step includes administering amedication dose, e.g., an insulin dose, determined according to themethod to the subject via a medication delivery device positioned at adistance from the analyte meter and in communication with the analytemeter.

A medication dose, e.g., a bolus dose, determined according to the abovemethods can be displayed to the user via optional display unit 108 ofanalyte meter 100.

As discussed previously herein, analyte sensors 200 and analyte meters100 can be configured for orientation non-specific insertion of theanalyte sensor 200 into analyte meter 100. By orientation non-specificinsertion, it is meant that either the first substrate or the secondsubstrate can be upward facing when the proximal end of analyte sensor200 is inserted into the sensor port of a corresponding analyte meter.That is, either the first substrate 201 or the second substrate 202 canbe upward facing when the proximal end of the sensor is inserted intoanalyte meter 100. As such, during a method of using analyte meter 100with analyte sensor 200, the analyte sensor 200 can be inserted ineither of the above orientations without negatively affecting theresults of the assay.

Method for Facilitating the Correct Insertion of an Analyte Sensor intoan Analyte Meter

The present disclosure provides a method for facilitating the correctinsertion of an analyte sensor into an analyte meter. In one embodiment,the method includes providing an analyte meter configured to receive ananalyte sensor, wherein the analyte meter includes a first demarcation.The method also includes providing an analyte sensor configured forinsertion into the analyte meter. The analyte sensor includes a seconddemarcation which together with the first demarcation indicates aninsertion orientation for the analyte sensor.

The demarcations can include, e.g., a color, a design or portionthereof, a pattern of indentations, a pattern of raised areas, or acombination thereof.

In the embodiment shown in FIG. 9, panel A, for example, analyte sensor200 includes a checkerboard pattern on a first face of analyte sensor200. This demarcation corresponds to a checkerboard pattern present on afirst face of analyte meter 100. Together the demarcations indicate aninsertion orientation for the analyte sensor, i.e., checkerboard sideup, to a user of the analyte sensor 200 and analyte meter 100. In thisembodiment, the demarcations provide a Y-axis orientation for insertionof analyte sensor 200.

FIG. 9, panel B, shows analyte sensor 200 and analyte meter 100, whereina first face of analyte sensor 200 includes the checkerboard pattern ofFIG. 9, panel A, and a second face of analyte sensor 200 includes apattern of vertical lines. Analyte meter 100 has a first face whichincludes a corresponding checkerboard pattern and a second face whichincludes a corresponding pattern of vertical lines. Together thedemarcations indicate an insertion orientation for the analyte sensor,i.e., checkerboard side up and vertical lines positioned to the right,to a user of the analyte sensor 200 and analyte meter 100. In thisembodiment, the demarcations provide an X and Y-axis orientation forinsertion of analyte sensor 200.

FIG. 9, panel C, shows a third embodiment in which analyte sensor 200includes an arrow design positioned on a first face of analyte sensor200 towards the proximal end of analyte sensor 200. Analyte meter 100includes a corresponding arrow design positioned on a first face ofanalyte meter 100. The arrow designs are positioned such that whenanalyte sensor 200 is correctly inserted into analyte meter 100 the tipsof the arrows appear to be in contact when the analyte sensor and meterare viewed from the top. As with the embodiment of FIG. 9, panel B, thedemarcations of this embodiment provide an X and Y-axis orientation forinsertion of analyte sensor 200.

While the present invention has been described with reference to thespecific embodiments thereof, it should be understood by those skilledin the art that various changes may be made and equivalents may besubstituted without departing from the true spirit and scope of theinvention. In addition, many modifications may be made to adapt aparticular situation, material, composition of matter, process, processstep or steps, to the objective, spirit and scope of the presentinvention. All such modifications are intended to be within the scope ofthe claims appended hereto.

What is claimed is:
 1. A method for determining a concentration of ananalyte in a fluid sample, the method comprising: positioning a sensorin a sensor port of an analyte meter, wherein the sensor port comprisesa first electrode contact and a second electrode contact, detecting, bythe analyte meter, an orientation of the sensor upon positioning of thesensor in the sensor port, configuring, by the analyte meter, one of thefirst electrode contact and the second electrode contact as a referenceand/or counter electrode contact; depositing a fluid sample on thesensor; and determining the concentration of the analyte using thesensor.
 2. The method of claim 1, wherein the sensor port is configuredto receive a sensor comprising opposing working and reference and/orcounter electrodes or coplanar working and reference and/or counterelectrodes.
 3. The method of claim 1, wherein the analyte is glucose orketone bodies.
 4. The method of claim 1, wherein the analyte meter isactivated upon positioning of the sensor in the sensor port.
 5. Themethod of claim 4, wherein the sensor comprises a turn-on/selectionmonitor, the sensor port comprises a turn-on/selection contact, and theturn-on/selection monitor contacts the turn-on/selection contact uponpositioning of the sensor in the sensor port, thereby activating theanalyte meter.
 6. The method of claim 5, wherein contact of theturn-on/selection contact with the turn-on/selection monitor opens orcloses an electrical circuit, wherein opening or closing of theelectrical circuit indicates the orientation of the sensor.
 7. Themethod of claim 1, wherein the sensor port comprises a firstturn-on/selection contact and a second turn-on/selection contact,wherein the first turn-on/selection contact and the secondturn-on/selection contact are positioned in an opposing configuration inthe sensor port.
 8. The method of claim 1, wherein the analyte meterdetects the orientation of the sensor by physical, mechanical, optical,or electrical means.
 9. The method of claim 1, wherein the analyte meterdetects the orientation of the sensor by detecting the opening of anelectrical circuit upon positioning of the sensor in the sensor port.10. The method of claim 1, wherein the analyte meter detects theorientation of the sensor by detecting closing of an electrical circuitupon positioning of the sensor in the sensor port.
 11. The method ofclaim 1, wherein the analyte meter is configured to perform an algorithmto determine a medication dose based on a determined concentration ofanalyte, and wherein the method further comprises determining themedication dose based on the determined concentration of analyte. 12.The method of claim 11, wherein the analyte meter further comprises amedication delivery device for administering a medication dose to asubject, wherein the medication dose is determined by the analyte meterusing the algorithm, and wherein the method further comprisesadministering the medication dose to the subject using the medicationdelivery device.
 13. The method of claim 12, wherein the analyte isglucose and the medication is insulin.
 14. The method of claim 12,wherein the medication delivery device comprises a needle, syringe,pump, catheter, inhaler, transdermal patch or combination thereof todeliver the medication dose.
 15. The method of claim 1, wherein theanalyte meter determines the concentration of the analyte byamperometry, coulometry, potentiometry, and/or voltammetry.
 16. Themethod of claim 1, wherein the sensor port is configured to receive thesensor comprising two electrodes, three electrodes, or four electrodes.